PMA
P190026: therascreen BRAF V600E RGQ PCR Kit
FDA PMA · Somatic gene mutation detection system · QIAGEN GmbH
Key facts
| PMA number | P190026 |
|---|---|
| Trade name | therascreen BRAF V600E RGQ PCR Kit |
| Generic name | Somatic gene mutation detection system |
| Applicant | QIAGEN GmbH |
| Owner/operator | QIAGEN, GmbH |
| Product code | OWD |
| Approval date | Apr 15, 2020 |
| Docket number | 20M-1290 |
| Notice date | Apr 17, 2020 |
| Establishment registration | 3004013603 |
| FEI number | 3004013603 |
At a glance
- 1–9 Supplements
- Jun 27, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: